Sr. Quality Engineer

Precision One Medical; Oceanside (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

Precision One Medical is seeking a Senior Quality Engineer to lead quality initiatives across manufacturing. You will support validations, drive process controls, and mentor junior engineers in a collaborative, regulated environment.

The role emphasizes data-driven improvements, regulatory compliance with FDA QSR and ISO13485, and cross-functional teamwork to ensure product quality and successful audits.

Qualifications

• Bachelor's degree in engineering with 5+ years of experience.
• Master's degree in engineering with 3+ years of experience.
• ASQ certification preferred (e.g., Quality Engineer, Auditor).

Responsibilities

• Adhere to Quality Management System to ensure regulatory compliance.
• Lead investigations for CAPAs, NMRs, and customer complaints with effective, measurable actions.
• Develop and standardize QA/QC processes, validation methodologies, inspection systems, and manufacturing controls.
• Provide technical leadership for manufacturing process controls and product quality issues.
• Analyze quality and manufacturing data to identify trends and improvement opportunities using statistics and risk-based logic.
• Support validations, documentation change processes, supplier quality control, and audit programs.
• Mentor junior quality engineers and communicate status to senior management.
• Collaborate with other departments to drive continuous improvement.

Skills

FDA QSR 21 CFR 820 knowledge

ISO13485 knowledge

SPC

DOE

statistical methods

Education

Bachelor's in engineering (5+ yrs)

Master's in engineering (3+ yrs)

Tools

ASQ Certification

Job description

SUMMARY

The Senior Quality Engineer serves as a technical quality leader focused on improving manufacturing performance, strengthening process controls, and driving scalable quality solutions across the organization. The role works closely with cross-functional teams to support validation activities, root cause investigations, process optimization, and quality system initiatives while promoting a culture of continuous improvement and regulatory compliance.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Adhere to the Company's Quality Management System to ensure compliance with applicable regulatory requirements.
• Lead investigations for CAPA's, NMR's, customer complaints, etc. by ensuring that corrective and preventative actions are effective, sustainable, and measurable
• Drive the development and standardization of quality assurance and quality control processes, validation methodologies, inspection systems, and manufacturing controls across the organization
• Provide technical leadership and subject matter expertise for manufacturing process controls, inspection methods, product quality issues, etc.
• Analyze quality and manufacturing data to identify trends, recurring issues, and opportunities for improvement using statistical methods and risk-based logic
• Drive efforts related to new product development, process transfers, major scale-up activities, etc.
• Support and perform tasks related to validations
• Support and perform tasks related to documentation change processes
• Support and perform tasks related to supplier quality control
• Support and perform tasks related to the company audit program
• Provide technical guidance and mentorship to junior quality engineers as required
• Provide ongoing communication and regular status updates to senior management team
• Interface and collaborate with other departments, stakeholders, etc.
• Perform special assignments as directed by supervision commensurate with experience.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
• Promote and maintain a safe work environment by following all company safety policies, procedures, and work instructions, and by promptly reporting unsafe conditions, incidents, or concerns to supervision.
• Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES

Direct Reports: Yes N/A

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Strong knowledge of the FDA Quality System Regulations (21 CFR Part 820) & (ISO13485: 2016).
• Working knowledge of SPC, DOE, probability, and statistics
• Prior successful testing and validation of manufacturing processes in a machining environment
• Ability to demonstrate technical expertise and communicate with internal and external customers and executive management
• Must be deadline- and detail-oriented, an effective communicator, and able to work within a team environment

EDUCATION AND/OR EXPERIENCE

• Bachelor's degree in an engineering-related field with 5+ years of experience

• Master's degree in an engineering-related field with 3+ years of experience

CERTIFICATES, LICENSES, REGISTRATIONS

• ASQ certification preferred (e.g., Quality Engineer, Auditor, etc.)

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The manufacturing environment is an industrial setting dedicated to the production and assembly of medical devices that utilizes machinery, equipment, and specialized processes to transform raw materials into finished products. This position's time is split between office and manufacturing environments.

PHYSICAL DEMANDS

Analysis of Physical Demands N=Never, R=Rarely Less than 1 hour per week, O=Occasional 1% to 33% of time, F=Frequent 34% to 66% of time, C=Constant over 66% of time Activity Frequency Activity Frequency Lifting/Carrying N R O F C Twisting/Turning N R O F C Under 10 lbs Reach over shoulder 11-20 lbs Reach over head 21-50 lb Reach outward 51-100 lbs Climb Over 100 lbs Crawl Pushing/Pulling N R O F C Kneel Under 10 lbs Squat 11-20 lbs Sit 21-50 lbs Walk-Normal Surfaces 51-100 lbs Walk-Uneven Surfaces Over 100 lbs Walk-Slippery Surfaces Other N R O F C Stand Keyboard/Ten Key Bend Fingering (fine dexterity) Driving N R O F C Handling (grasping, holding) Automatic Trans Repetitive Motion - Hands Standard Trans Repetitive Motion - Feet

Monday - Thursday 5:30 am - 3:30 pm